Mar 29, 2022

Job Description

More than 52 different medical diseases! Novartis Global Drug Development portfolio includes a large number of innovative platform studies with more than 90 projects in clinical development, of which this safety position will play a key leadership role in supporting patient safety for breakthrough innovative medicines.

As our Global Program Safety Lead within Cardio Metabolics you will be part of a high performing team that aspires to reverse atherosclerotic cardiovascular disease. The team are working on development of a novel therapy, for a disease that does not have an effective treatment option.

Your responsibilities will include, but are not limited to:

• Provide expert safety input to the clinical development program for assigned projects/products and be an active member of the Global Program Team (GPT), Global Clinical Team (GCT) and Clinical Trial Team (CTT)
• Ownership for safety issue management from formation of Global Program Team (GPT) through Life Cycle Management.
• Develop and manage key internal Novartis safety documents: reviewing these documents regularly and updating as required. Managing the documentation/tracking/record keeping of the assigned compounds medical safety activities.
• Initial development and ongoing maintenance of safety information in Core Data Sheet (core global labeling), including addressing safety issues optimally in all project/product labeling indications.
• Responsible for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post-marketing data, and other sources.
• Lead the preparation of the safety strategy for health authority responses and strategy, in collaboration with other project team members. Manage responses to inquiries from regulatory authorities or health care professionals on safety issues.
• Contributes to and often leads the development of departmental and functional/business unit goals and objectives

Some restrictions to flexible working models may apply and will be discussed at interview if relevant

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

What you’ll bring to the role:

• MD preferred (PhD, PharmD)
• Proficiency English (oral and written)
• 3-4 years relevant experience Medical Safety, Benefit/Risk Evaluation, Epidemiology Post Authorization, Data Safety
• Strong interpersonal, communication, negotiation and problem solving skills.

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!
Global Drug Development
Research & Development
Full Time
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Global Program Safety Lead - Cardio Metabolics (80- 100%)

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